A Study of Multiple Olomorasib (LY3537982) Capsules in Healthy Participants
An Open-Label, Randomized, 3-Way Crossover Study Comparing the Pharmacokinetics of Multiple Olomorasib (LY3537982) Capsules
2 other identifiers
interventional
120
1 country
2
Brief Summary
The main purpose of this study is to measure how much olomorasib gets into the bloodstream and how long it takes the body to get rid of it. Healthy participants will take olomorasib by mouth. The study will last about 7 weeks and will include 10 back-to-back overnight stays in the research center.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jul 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2025
CompletedFirst Posted
Study publicly available on registry
June 29, 2025
CompletedStudy Start
First participant enrolled
July 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2025
CompletedMay 29, 2026
May 1, 2026
4 months
June 26, 2025
May 27, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Time t (AUC[0-tlast]) of Olomorasib
PK: AUC(0-tlast) of Olomorasib
From Day 1, Predose up to 72 hours Postdose
PK: Area Under the Concentration versus Time Curve from Zero to Infinity (AUC[0-∞]) of Olomorasib
PK: AUC(0-∞) of Olomorasib
From Day 1, Predose up to 72 hours Postdose
PK: Maximum Observed Drug Concentration (Cmax) of Olomorasib
PK: Cmax of Olomorasib
From Day 1, Predose up to 72 hours Postdose
Study Arms (3)
Olomorasib - (Test Formulation 1)
EXPERIMENTALOlomorasib administered orally
Olomorasib - (Test Formulation 2)
EXPERIMENTALOlomorasib administered orally
Olomorasib - (Reference Formulation)
ACTIVE COMPARATOROlomorasib administered orally
Interventions
Single dose
Eligibility Criteria
You may qualify if:
- Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
- Body mass index (BMI): 18.0 to 30.0 kilograms per square meter (kg/m²), inclusive
- Participants assigned male at birth (AMAB) or assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP).
You may not qualify if:
- Females who are lactating or of childbearing potential
- Clinically significant history of any drug sensitivity, drug allergy, or food allergy
- Have used or plan to use medication within 14 days or 5 half-lives, whichever is longest, prior to admission, with the exception occasional acetaminophen at doses less than or equal to 2 g/day.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
ICON Early Phase Services
San Antonio, Texas, 78209, United States
ICON
Salt Lake City, Utah, 84124, United States
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2025
First Posted
June 29, 2025
Study Start
July 11, 2025
Primary Completion
November 8, 2025
Study Completion
November 8, 2025
Last Updated
May 29, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share